Neuromuscular BlockPhase 4LidoRocNCT00828373
The Influence of Intravenous Lidocaine on the Action of the Neuromuscular Blocker Rocuronium
A Phase 4 study testing Lidocaine in people with Neuromuscular Block, run by University Hospital, Geneva at 1 site in Switzerland.
Trial summary
Lidocaine is a local anesthetic which is widely used in daily anesthesia and surgical practice. It has been shown that intravenous lidocaine given during an operation has analgesic properties. Finally intravenous lidocaine is inexpensive and easy to administer and safe if non-toxic doses are respected. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Neuromuscular Block
- What is being tested?
- Lidocaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteSwitzerland
- Study dates
- Aug 2009to Aug 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adult, age ≥18 to 60 years, male or female.
- American Society of Anesthesiology [ASA] status I or II.
- Patient is able to read and understand the information sheet and to sign and date the consent form.
- Patient scheduled of elective surgery lasting longer than 120 min without need for continuous curarisation.
- Surgery without application of local anesthetics (epidurals, wound-infiltration).
- If the patient is female and of childbearing potential, she must have a negative pregnancy test.
Who cannot join
- A history of allergy or hypersensitivity to rocuronium or lidocaine
- Neuromuscular disease
- Preoperative medications known to influence neuromuscular function (for instance, certain antibiotics [aminoglycosides] and anticonvulsants [phenytoine])
- Electrolyte abnormalities (for instance, hypermagnesemia)
- Hepatic or renal insufficiency
- Patients with epileptic disease
Show all 10Show fewer
- Patients with a body mass index <19 or >28 kg m2
- Pregnant or breastfeeding women
- Expected difficult intubation or mask ventilation
- Atrioventricular heart block II or III -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Intravenous Lidocaine on the Time Course of Rocuronium Induced Neuromuscular Block. A Randomised, Placebo-controlled, Electrophysiological Study
Lidocaine is a local anesthetic which is widely used in daily anesthesia and surgical practice. It has been shown that intravenous lidocaine given during an operation has analgesic properties. Finally intravenous lidocaine is inexpensive and easy to administer and safe if non-toxic doses are respected. It is likely that the use of lidocaine infusions during anesthesia might increase in the coming years. Neuromuscular blockers (curare like substances) are used in anesthesia to facilitate tracheal intubation and to achieve muscle relaxation and immobility during surgery. Rocuronium is one of the most widely used neuromuscular blocking agents. Local anesthetics, such as lidocaine, are known to potentiate the effect of neuromuscular blocking agents. In the study the investigators want to evaluate the effect of intravenous lidocaine during the operation on the time course of the rocuronium-induced neuromuscular block. A secondary aim is to evaluate intubation conditions (lidocaine has been shown also to improve intubation conditions) and safety.
- Conditions
- Neuromuscular Block
- Being tested
- Placebo, Lidocaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Immediately before induction, patients will receive 0.15 ml kg-1 of the study drug as an intravenous bolus followed, after tracheal intubation, by a continuous intravenous infusion of 0.2 ml kg-1 h-1. In the Placebo group this will be physiologic saline. The infusion will be stopped after complete recovery from the neuromuscular block.
LidocaineDrug
Also called Rapidocaïne®, Xylocain®
Immediately before induction, patients will receive 0.15 ml kg-1 of the study drug as an intravenous bolus followed, after tracheal intubation, by a continuous intravenous infusion of 0.2 ml kg-1 h-1. In the lidocaine Arm this regimen corresponds to 1.5 mg kg-1 lidocaine bolus injection and 2 mg kg-1 h-1 lidocaine continuous infusion. The infusion will be stopped after complete recovery from the neuromuscular block.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Lidocaine | Active comparator | Not described Receives: Drug: Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Onset and recovery of the neuromuscular block
Measured: From start of injection of rocuronium until TOF 90%
Secondary outcomes (2)
To evaluate intubation conditions at T1, we will use the scale according to the Good Clinical Research practice (GRCP) in neuromuscular research
Measured: 2 to 3 minutes
Any minor adverse event (no need for intervention) or major adverse event will be recorded.
Measured: up to 5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2009 (estimated)
- Study startAug 2009
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neuromuscular BlockStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Investigators
- Christoph A Czarnetzki, MD, MBA, Principal investigator, University Hospitals of GenevaMartin R Tramèr, MD, Dphil, Study chair, University Hospitals of Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00828373
- Sponsor's protocol ID
- CER 08 - 202
- Other IDs
- Swissmedic
- Acronym
- LidoRoc
- Status last verified
- Aug 2009
- First submitted
- 22 Jan 2009
- Last updated
- 15 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Czarnetzki C, Lysakowski C, Elia N, Tramer MR. Intravenous lidocaine has no impact on rocuronium-induced neuromuscular block. Randomised study. Acta Anaesthesiol Scand. 2012 Apr;56(4):474-81. doi: 10.1111/j.1399-6576.2011.02625.x. Epub 2012 Jan 19.
PubMed 22260297
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intravenous Lidocaine on the Time Course of Rocuronium Induced Neuromuscular Block. A Randomised, Placebo-controlled, Electrophysiological Study
- ClinicalTrials.gov ID
- NCT00828373
- Acronym / sponsor ID
- LidoRoc / CER 08 - 202
- Conditions
- Neuromuscular Block
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 23 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Lidocaine is a local anesthetic which is widely used in daily anesthesia and surgical practice. It has been shown that intravenous lidocaine given during an operation has analgesic properties. Finally intravenous lidocaine is inexpensive and easy to administer and safe if non-toxic doses are respected. It is likely that the use of lidocaine infusions during anesthesia might increase in the coming years. Neuromuscular blockers (curare like substances) are used in anesthesia to facilitate tracheal intubation and to achieve muscle relaxation and immobility during surgery. Rocuronium is one of the most widely used neuromuscular blocking agents. Local anesthetics, such as lidocaine, are known to potentiate the effect of neuromuscular blocking agents. In the study the investigators want to evaluate the effect of intravenous lidocaine during the operation on the time course of the rocuronium-induced neuromuscular block. A secondary aim is to evaluate intubation conditions (lidocaine has been shown also to improve intubation conditions) and safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| Lidocaine | Active comparator | Drug: Lidocaine |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Adult, age ≥18 to 60 years, male or female.
- American Society of Anesthesiology [ASA] status I or II.
- Patient is able to read and understand the information sheet and to sign and date the consent form.
- Patient scheduled of elective surgery lasting longer than 120 min without need for continuous curarisation.
- Surgery without application of local anesthetics (epidurals, wound-infiltration).
Key exclusion criteria (10 listed)
- A history of allergy or hypersensitivity to rocuronium or lidocaine
- Neuromuscular disease
- Preoperative medications known to influence neuromuscular function (for instance, certain antibiotics [aminoglycosides] and anticonvulsants [phenytoine])
- Electrolyte abnormalities (for instance, hypermagnesemia)
- Hepatic or renal insufficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboImmediately before induction, patients will receive 0.15 ml kg-1 of the study drug as an intravenous bolus followed, after tracheal intubation, by a continuous intravenous infusion of 0.2 ml kg-1 h-1. In the Placebo group this will be physiologic saline. The infusion will be stopped after complete recovery from the neuromuscular block. | Drug | Placebo |
| LidocaineAlso: Rapidocaïne®, Xylocain®Immediately before induction, patients will receive 0.15 ml kg-1 of the study drug as an intravenous bolus followed, after tracheal intubation, by a continuous intravenous infusion of 0.2 ml kg-1 h-1. In the lidocaine Arm this regimen corresponds to 1.5 mg kg-1 lidocaine bolus injection and 2 mg kg-1 h-1 lidocaine continuous infusion. The infusion will be stopped after complete recovery from the neuromuscular block. | Drug | Lidocaine |
Primary outcome
Onset and recovery of the neuromuscular block
Time frame: From start of injection of rocuronium until TOF 90%
2 secondary outcomes
To evaluate intubation conditions at T1, we will use the scale according to the Good Clinical Research practice (GRCP) in neuromuscular research
Time frame: 2 to 3 minutes
Any minor adverse event (no need for intervention) or major adverse event will be recorded.
Time frame: up to 5 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2011.
- Derived from this study: PubMed 22260297Czarnetzki C, Lysakowski C, Elia N, Tramer MR. Intravenous lidocaine has no impact on rocuronium-induced neuromuscular block. Randomised study. Acta Anaesthesiol Scand. 2012 Apr;56(4):474-81. doi: 10.1111/j.1399-6576.2011.02625.x. Epub 2012 Jan 19.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christoph A Czarnetzki, MD, MBA principal investigator
University Hospitals of Geneva
Martin R Tramèr, MD, Dphil study chair
University Hospitals of Geneva
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lidocaine in people with Neuromuscular Block, run by University Hospital, Geneva at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Onset and recovery of the neuromuscular block (time frame: From start of injection of rocuronium until TOF 90%). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00828373, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2011.